Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes

PHASE3CompletedINTERVENTIONAL
Enrollment

205

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

December 1, 2013

Study Completion Date

December 31, 2021

Conditions
Childhood Acute Basophilic LeukemiaChildhood Acute Eosinophilic LeukemiaChildhood Acute Erythroleukemia (M6)Childhood Acute Megakaryocytic Leukemia (M7)Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)Childhood Acute Monoblastic Leukemia (M5a)Childhood Acute Monocytic Leukemia (M5b)Childhood Acute Myeloblastic Leukemia With Maturation (M2)Childhood Acute Myeloblastic Leukemia Without Maturation (M1)Childhood Acute Myelomonocytic Leukemia (M4)Childhood Myelodysplastic Syndromesde Novo Myelodysplastic SyndromesSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesUntreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Interventions
DRUG

asparaginase

Given IM

DRUG

daunorubicin hydrochloride

Given IV

DRUG

cytarabine

Given IV or IT

DRUG

thioguanine

Given orally

DRUG

etoposide

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

Trial Locations (97)

6008

Princess Margaret Hospital for Children, Perth

10032

Columbia University Medical Center, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

10595

Ny Cancer%, Valhalla

13210

State University of New York Upstate Medical University, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester, Rochester

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17033

Penn State Hershey Children's Hospital, Hershey

19104

Children's Hospital of Philadelphia, Philadelphia

19134

Saint Christopher's Hospital for Children, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

20010

Children's National Medical Center, Washington D.C.

20057

Lombardi Comprehensive Cancer Center at Georgetown University, Washington D.C.

21215

Sinai Hospital of Baltimore, Baltimore

21287

Johns Hopkins University-Sidney Kimmel Cancer Center, Baltimore

23507

Childrens Hospital-King's Daughters, Norfolk

27599

University of North Carolina, Chapel Hill

27710

Duke University Medical Center, Durham

28203

Carolinas Medical Center, Charlotte

29203

Palmetto Health Richland, Columbia

30322

Children's Healthcare of Atlanta - Egleston, Atlanta

32803

Florida Hospital, Orlando

33021

Memorial Healthcare System - Joe DiMaggio Children's Hospital, Hollywood

33316

Broward Health Medical Center, Fort Lauderdale

33701

All Children's Hospital, St. Petersburg

37232

Vanderbilt-Ingram Cancer Center, Nashville

38105

St. Jude Children's Research Hospital, Memphis

39216

University of Mississippi Medical Center, Jackson

40202

Kosair Children's Hospital, Louisville

43205

Nationwide Children's Hospital, Columbus

44195

Cleveland Clinic Foundation, Cleveland

44308

Children's Hospital Medical Center of Akron, Akron

46202

Indiana University Medical Center, Indianapolis

Riley Hospital for Children, Indianapolis

46260

Saint Vincent Hospital and Health Services, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

48201

Wayne State University-Karmanos Cancer Institute, Detroit

48236

Saint John Hospital and Medical Center, Detroit

48502

Hurley Medical Center, Flint

49503

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids

53226

Midwest Children's Cancer Center, Milwaukee

55404

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis

55455

University of Minnesota Medical Center-Fairview, Minneapolis

58122

Sanford Medical Center-Fargo, Fargo

60068

Advocate Lutheran General Hospital., Park Ridge

60153

Loyola University Medical Center, Maywood

60614

Lurie Children's Hospital-Chicago, Chicago

61602

Saint Jude Midwest Affiliate, Peoria

62702

Southern Illinois University, Springfield

64108

The Childrens Mercy Hospital, Kansas City

68114

Children's Hospital and Medical Center of Omaha, Omaha

68198

University of Nebraska Medical Center, Omaha

70112

Tulane University Health Sciences Center, New Orleans

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75390

University of Texas Southwestern Medical Center, Dallas

76104

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine, Houston

79410

Covenant Children's Hospital, Lubbock

80045

Children's Hospital Colorado, Aurora

83712

Saint Luke's Mountain States Tumor Institute, Boise

84113

Primary Children's Hospital, Salt Lake City

85016

Phoenix Childrens Hospital, Phoenix

89106

Nevada Cancer Research Foundation CCOP, Las Vegas

90027

Children's Hospital Los Angeles, Los Angeles

90242

Southern California Permanente Medical Group, Downey

90806

Miller Children's Hospital, Long Beach

92123

Rady Children's Hospital - San Diego, San Diego

94143

University of California San Francisco Medical Center-Parnassus, San Francisco

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

94611

Kaiser Permanente-Oakland, Oakland

96813

University of Hawaii, Honolulu

97227

Legacy Emanuel Hospital and Health Center, Portland

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

98405

Mary Bridge Children's Hospital and Health Center, Tacoma

93636-8762

Children's Hospital Central California, Madera

94609-1809

Children's Hospital and Research Center at Oakland, Oakland

92868-3874

Childrens Hospital of Orange County, Orange

32207-8426

Nemours Children's Clinic - Jacksonville, Jacksonville

04401

Eastern Maine Medical Center, Bangor

20889-5600

Walter Reed National Military Medical Center, Bethesda

07601

Hackensack University Medical Center, Hackensack

08901

Saint Peter's University Hospital, New Brunswick

08903

UMDNJ - Robert Wood Johnson University Hospital, New Brunswick

07112

Newark Beth Israel Medical Center, Newark

02903

Rhode Island Hospital, Providence

78229-3900

University of Texas Health Science Center at San Antonio, San Antonio

05401

University of Vermont, Burlington

V6H 3V4

British Columbia Children's Hospital, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

A1B 3V6

Janeway Child Health Centre, St. John's

K7L 5P9

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston

N6A 5W9

Children's Hospital, London

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

Hospital for Sick Children, Toronto

00912

San Jorge Children's Hospital, Santurce

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT00369317 - Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes | Biotech Hunter | Biotech Hunter